CMC Expert – Analytical Development for Parenterals & Devices

About the role

Roche is seeking a senior CMC expert to lead analytical development for parenteral products and combination devices. You will provide scientific guidance, mentor teams, and drive strategic CMC decisions across the portfolio.

Key responsibilities

• Provide expert scientific input to project teams and leadership within Analytical R&D.
• Lead NDA authoring, due‑diligence processes, and resolution of complex CMC issues.
• Design and implement portfolio‑wide risk mitigation and continuous‑improvement initiatives.
• Collaborate cross‑functionally to identify new scientific opportunities and drive R&D Excellence projects.

Required profile

• Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry or related field.
• Extensive experience in analytical development of parenterals and combination products with devices.
• Proven track record in NDA preparation and transfer to commercial manufacturing.
• Strategic problem‑solver with strong analytical and communication skills.

Required skills

• Analytical development of parenteral formulations.
• Combination product and device integration expertise.
• Experience with oligonucleotides, peptides and small‑molecule modalities.
• CMC issue resolution, root‑cause analysis and risk mitigation.